F2 Labs’ is Officially Approved as an FDA ASCA-Accredited Testing Lab!

We are excited to announce that F2 Labs is officially an ASCA-accredited testing laboratory! We are one of only 17 labs approved by the FDA for this groundbreaking certification.

As an ASCA-accredited laboratory, we are certified to perform testing in accordance with the specifications of ISO/IEC 17025 and ASCA program specifications. This program will help increase product safety for the end-user and shorten the time it takes for FDA approval of your product.

What is ASCA?

The FDA launched ASCA to support its public health mission by increasing confidence in test results provided by testing laboratories. Becoming accredited comes with standards a laboratory must follow beyond the initial application process, including periodic audits. This helps ensure confidence with the FDA that we follow the proper procedures and help get your product through the FDA 510K process quicker.

The ASCA program will NOT introduce new requirements for medical device manufacturers. Instead, the ASCA intends to promote consistency and predictability in all of the FDA’s premarket submission programs.

When a lab is ASCA accredited, medical device manufacturers can be more confident that the lab conducting testing (within the laboratory’s scope of ASCA Accreditation) is likely to meet FDA’s regulatory requirements. Your products are no longer likely to be excluded from FDA approval because of an issue related to the lab’s testing if you use an ASCA Accredited lab in good standing.

The FDA believes the experience gained in the ASCA Pilot could broadly inform international harmonization efforts such as standards use across jurisdictions. ASCA is designed to increase manufacturer and consumer confidence in medical device testing, which will help ensure the widespread accessibility of safe and effective medical devices.

F2 Labs can provide more detail about the ASCA program as it relates to your product. You can also find more information and helpful resources at F2Labs.com. The ASCA program and F2 Labs’ accreditation through it, helps us fulfill our mission of partnering with our clients to make the world a safer place.

Please feel free to contact us if you have any questions.

This entry was posted in ASCA Program and tagged , , , , . Bookmark the permalink.